Essential Thrombocythemia

• FDA label_change · 2024-08-16
  FDA Approved: ANAGRELIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Anagrelide by Torrent Pharmaceuticals Limited, updating the labeling for the drug.

• FDA label_change · 2020-02-28
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda, resulting in changes to the product labe…

• FDA label_change · 2018-12-19
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda Pharmaceuticals America, Inc., updati…

• FDA label_change · 2015-07-14
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda Pharmaceuticals America, Inc. to update t…

• FDA label_change · 2014-02-07
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA page indicates Takeda submitted a supplemental NDA for AGRYLIN (anagrelide hydrochloride), signaling a labeling change under review.

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• FDA label_change · 2012-01-26
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) from Waylis Therapeutics LLC, indicating a label change/expansion. The docu…

• FDA label_change · 2009-07-09
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental NDA for AGRYLIN (anagrelide hydrochloride) submitted by Takeda to modify the product labeling.